UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008432 |
|---|---|
| Receipt number | R000009921 |
| Scientific Title | Investigation of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy |
| Date of disclosure of the study information | 2012/07/29 |
| Last modified on | 2021/12/05 21:23:53 |
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Basic information
Public title
Investigation of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Acronym
Lung cancer chemothrapy, diarrhea, and Clostridium difficile-colitis study
Scientific Title
Investigation of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Scientific Title:Acronym
Lung cancer chemothrapy, diarrhea, and Clostridium difficile-colitis study
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the incidence of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Basic objectives2
Others
Basic objectives -Others
To estimate the incidence of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Key secondary outcomes
a preventive effect of probiotics against Clostridium difficile-colitis after lung cancer chemotherapy
an effect of treatment for Clostridium difficile-colitis after lung cancer chemotherapy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
an age of at least 20 years
histologically or cytologically confirmed lung cancer
scheduled for chemotherapy of TS-1, CPT-11, or taxane-anticancer drugs
an Eastern Corporative Oncology Group (ECOG) performance status of 3 or less
without diarrhea
a life expectancy of at least 3 months
Key exclusion criteria
ileus
diarrhea for more than three times a day before the administration of the anticancer agent
a history of Clostridium difficile infection in the 2 months before enrollment
mental disorders require the administration of antipsychotic
major complications interfere with the continuation of the treatment
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Sugawara |
Organization
Sendai Kousei Hospital
Division name
respiratory medicine
Zip code
980-0873
Address
4-15,Hirosemachi,Aoba-ku,Sendai,Miyagai, Japan
TEL
81-22-222-6181
swara357@cat-v.ne.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kobayashi |
Organization
North Japan Lung Cancer Study Group
Division name
Sendai Kousei Hospital
Zip code
980-0873
Address
4-15,Hirosemachi,Aoba-ku,Sendai,Miyagai, Japan
TEL
81-22-222-6181
Homepage URL
ktakao@cat-v.ne.jp
Sponsor or person
Institute
North Japan Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
North Japan Lung Cancer Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai Kousei hospital
Address
4-15, Hirosemachi, Aoba-Ku, Sendai, Miyagi,Japan
Tel
81-22-222-6181
yuktoi119@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
https://doi.org/10.3389/fonc.2021.685320
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3389/fonc.2021.685320
Number of participants that the trial has enrolled
263
Results
Grade 2 or higher diarrhea was observed in 22 patients(8.4%); Clostridium difficile infection(CDI) was confirmed in five of them. The incidence of CDI was 22.7% of all diarrhea cases.
Results date posted
| 2021 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
lung cancer chemotherapy patients
Participant flow
Participants were enrolled by each institutes.
Adverse events
not observed
Outcome measures
Grade 2 or higher diarrhea was observed in 22 patients(8.4%); Clostridium difficile infection(CDI) was confirmed in five of them. The incidence of CDI was 22.7% of all diarrhea cases.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
record the case of diarrhea after lung cancer chemotherapy
Management information
Registered date
| 2012 | Year | 07 | Month | 13 | Day |
Last modified on
| 2021 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009921
